IE913442A1 - Compositions containing psyllium - Google Patents

Abstract

Calcium lactate coated psyllium fiber composition and psyllium-containing baked cookie composition having high fiber content and good eating qualities. These baked cookies comprise calcium lactate coated psyllium fiber, insoluble dietary fiber, shortening, flour, sugar and water. Eating quality of these psyllium-containing cookies is especially enhanced by their reduced tendency for the composition to stick to and/or form a film on teeth during ingestion.

Description

BACKGROUND OF THE INVENTION The present invention relates to calcium lactate coated psyllium compositions, especially high fiber baked cookies comprising calcium lactate coated psyllium, and to methods for preparing these compositions. These cookies essentially comprise calcium lactate coated psyllium and (preferably) insoluble dietary fiber, flour, shortening and water. These baked cookies have excellent texture, mouthfeel and palatability. They are useful as dietary aids in the control of bowel function (including use as laxatives) and/or for reducing blood cholesterol levels and/or for weight control or other indications where fiber may be beneficial.

U.S. Patent 4,784,861, to Gor1, issued November 15, 1988, describes powders formed of a mixture of oat, wheat and corn bran mixed with pectin, guar gum, psyllium and cutin to which mineral supplements have been added. U.S. Patent 4,619,831, to Sharma, issued October 28, 1986, describes dietary fiber products comprising insoluble dietary fiber (92-98.5%) coated or enrobed with soluble dietary fiber (1.5-8%; psyllium is mentioned as one of many soluble fibers). U.S. Patent 4,565,702, to Morley et al., issued January 21, 1986, describes dietary fiber compositions comprising dietary fibers which are Insoluble fibers coated with soluble fiber. U.S. Patent 4,348,379, to Kowalsky et al., issued September 7, 1982, describes dietetic compositions comprising psyllium seed, 1 Inseed, and wheat bran. European Patent Application Publication No. 144,644, published June 19, 1985 by G. 0.

Searle and Co., describes high fiber food compositions comprising psyllium and other dietary fiber sources.

West German Patent Specification 2,430,509, published January 15, 1976 by Hypolab S.A., Genf. (Schweiz), describes preparing compositions containing bulk laxatives (including psyllium mucilloid) in the form of a cake. The cake dough is prepared and baked in molds to produce cakes having thickness of 3-6 mm. - 2 Reduced calorie baked cookies containing microcrystalline cellulose as a preferred bulking agent are disclosed in U.S. Patent 4,668,519, to Dartey et al., issued May 26, 1987. This patent indicates that these cookies can optionally include bulking agents such as dietary fibers (including psyllium fiber) at levels up to about 10% by weight of the dough.

Great Britain Patent Specification 1,590,507, published June 3, 1981, by Syntex (U.S.A.) Inc., describes compositions comprising mixtures of purified cellulose and pectin as a source of dietary fiber. The effectiveness of these compositions for controlling fecal output in humans is compared versus various other compositions, including biscuits which comprise only psyllium.

Several other U.S. patents describe non-baked compositions in which psyllium is described as an optional or essential ingredient: 4,778,676, to Yang et al., issued October 18, 1988 (describes chewable compositions comprising a precoated active and a confectionery matrix); 4,766,004, to Moskowitz, issued August 23, 1988 (describes dietary fiber supplement compositions comprising whole psyllium husks having a particle size of from 12 to 70 mesh, food grade vegetable fat which is a solid at room temperature, sweetening agent and flavoring agent); 4,737,364, to Kalogris, issued April 12, 1988 (describes low calorie dry food concentrate); 4,698,232, to Sheu et al., issued October 6, 1987 (describes fiber-containing confectionery compositions comprising dietary fiber pretreated with a lubricant, a foamed matrix, and an amorphous matrix); and 4,551,331, to Rudin, issued November 5, 1985 and R.E. 32,811, issued December 27, 1988 (describe dietary fiber products comprising a dietary fiber coated with a food grade emulsifier).

In addition to the preceding publications, the following publications are also worth mentioning herein: U.S. Patent 3,219,455, to Dubois, issued November 23, 1965; U.S. Patent 4,461,782, to Robbins et al., issued July 24, 1984; U.S. Patent 3,954,976, to Mattson et al., issued May 4, 1976; U.S. Patent 4,005,195, to Jandacek, issued January 25, 1977; U.S. Patent 4,005,196, to Jandacek et al., issued January 25, 1977; U.S.

Patent 4,034,083, to Mattson, Issued July 5, 1977; U.S. Patent 3,455,714, to Bishop et al., issued July 15, 1969; U.S. Patent 4,321,263, to Powell et al., issued March 23, 1982; U.S. Patent 4,673,578, to Becker et al., issued June 16, 1987; U.S. Patent 4,568,557, to Becker et al., issued February 4, 1986; U.S. Patent 2,060,336, to Near et al., issued April 5, 1933; U.S. Patent 4,156,021, to Richardson, issued May 22, 1979; U.S. Patent 4,089,981, to Richardson, issued May 16, 1978; U.S. Patent 3,023,104, to Battista, issued February 27, 1962; U.S. Patent 4,511,561, to Madaus et al., Issued April 16, 1985; U.S. Patent 4,459,280, to Colliopoulos et al., issued July 10, 1984; U.S.

Patent 4,341,805, to Chaudhary, issued July 27, 1982; U.S. Patent 4,181,747, to Kickle et al., issued January 1, 1980; U.S. Patent 4,350,714, to Duvall, issued September 21, 1982; U.S. Patent 4,315,954, to Kuipers, issued February 16, 1982; U.S. Patent 3,992,147, to Christian et al., issued November 16, 1976; U.S. Patent 3,148,114, to Fahrenbach et al., issued September 8, 1964; U.S. Patent 4,639,367, to Mackies, Issued January 27, 1987; French Patent Specification 2,165,795, published December 31, 1971; European Patent Application Publication No. 105,195, published April 11, 1984; European Patent Application Publication No. 285,201, published October 5, 1988; Great Britain Patent Specification 2,067,402, published July 30, 1981; Great Britain Patent Specification 2,201,875, published September 14, 1988; World Patent Application Publication No. 80/00658, published April 17, 1980; Goodman & Gilman, The Pharmacologic Basis of Therapeutics, Fifth Edition, 979 (1975); Garvin et al., Proc, Soc, Exp, Biol.

Med.. 1212, 744-746 (1965); Forman et al., Proc, Soc, Exp, Biol.

Med.. 127. 1060-1063 (1968); Anderson et al., Fed, Proc.. 45» 877 (1987); Anderson et al., Am, J. Gastroenterol., fil, 907-919 (1986); and Faberberg, Curr. Ther. Res.. 21, 166 (1982).

In spite of the large amount of research aimed at developing portable and palatable compositions containing psyllium, there 1s a continuing need to provide additional compositions having psyllium at levels high enough to provide therapeutic benefits in - ♦ reasonably sized, portable compositions having good eating aesthetics. It has been discovered that such compositions can be prepared in the form of a cookie by using calcium lactate coated psyllium, preferably along with Insoluble fiber. The psyllium fiber coating comprises the polyvalent cation-containing material calcium lactate, and also preferably a Type A gelatin is employed to further coat the calcium lactate coated psyllium fibers. By using the calcium lactate coated psyllium fiber in these compositions, it has been surprisingly discovered that the eating quality of the cookie compositions are greatly enhanced, especially with regard to the stickiness of the composition (i.e., the tendency of the composition to stick to and/or form an unpleasant coating on the teeth during ingestion). Such compositions, and the methods for making them, are also well suited for large scale manufacture of portable, palatable and efficacious psyllium-containing cookies.

It is an object of the present invention to provide compositions which are convenient, portable and highly palatable (e.g., having excellent texture and mouthfeel) psyll1um-containing cookies. An object of the present Invention is also to provide convenient, portable psyll1um-conta1n1ng compositions having good consumer acceptance to promote compliance with a regimen for providing laxatlon benefits and/or reducing serum cholesterol levels and/or weight control. A further object 1s to provide psyllium-containing compositions having little or no gummy or rubbery texture and reduced stickiness during ingestion. Also, an object is to provide portable psyllium-containing compositions which are efficacious for providing laxation benefits and/or reducing serum cholesterol levels. Further, an object is to provide highly palatable compositions which provide both psyllium fiber and calcium. An object of the present invention 1s also to provide methods for preparing these efficacious baked cookie compositions.

These and other objects of the present invention will become readily apparent from the detailed description which follows. - 5 All percentages and ratios used herein are by weight unless otherwise specified, and all measurements are made at 25*C unless otherwise specified.

SUMMARY Of THE INVENTION The present invention relates to calcium lactate coated psyllium compositions. These compositions comprise from about 0.5% to about 10% of calcium lactate, and from about 85% to about 99.5% psyllium fiber, wherein the calcium lactate coats the psyllium fiber. Preferred is such compositions further comprising from about 1% to about 5% of Type A gelatin, wherein this gelatin also coats the calcium lactate coated psyllium fiber.

The present invention also relates to highly palatable psyllium-containing baked cookie compositions. These compositions comprise: from about 10% to about 20% calcium lactate coated psyllium fiber, from about 13% to about 20% of a shortening component, from about 10% to about 40% of a flour component, from about 5% to about 40% of a sugar component, from about 1.5% to about 3.5% water, and preferably from about 3% to about 17% of an insoluble dietary fiber.

The present invention also relates to methods for making the baked cookie compositions of the present invention. These methods comprise the steps of: (a) coating the psyllium fibers with calcium lactate and, optionally, Type A gelatin; (b) mixing to a uniform mass either sequentially or all at once the calcium lactate coated psyllium fiber (and preferably the insoluble fiber) with the remaining components of the cookie dough; and (c) baking the dough to reduce the water content of the cookie composition to within from about 1.5% to about 3.5% by weight of the baked cookie composition.

The present invention further relates to methods for reducing serum cholesterol levels, and for providing laxatlon and regulating bowel function. These methods comprise orally administering to a human in need of such treatment a safe and effective amount of a composition of the present invention. - 6 DETAILED DESCRIPTION OF THE INVENTION Calcium Lactate Coated Psyllium Compositions: The present invention relates to calcium lactate coated psyllium fiber compositions. These compositions comprise psyllium fiber coated with calcium lactate, and preferably also with Type A gelatin. (a) Psyllium Fiber: The term psyllium fiber, as used herein, means the seed coat of psyllium seed (either intact or macerated or otherwise comminuted). Psyllium fiber comes from psyllium seed, from plants of the Plantago genus. Various species such as Plantaao lanceolate. P, ruoelii. and P. ma.ior. are known. Commercial psyllium includes the French (black; Plantago indica), Spanish (P^. psyllium) and Indian (blonde; P. ovata). Indian (blonde) psyllium is preferred for use herein.

Intact or macerated seeds can be used in the practice of this invention. However, it is typical to remove the seed coats from the rest of the seed by, for example, slight mechanical pressure, and then to use only the seed coat. In the practice of the present Invention it is convenient and desirable to use macerated seed coat in the final composition. The seed coat is therefore preferably removed and sanitized by methods known in the art (e.g., ethylene oxide sanitization or steam sanitization as described 1n U.S. Patent 4,911,889, Issued March 27, 1990 to Leland et al., incorporated herein by reference in its entirety) prior to use in the present composition. Furthermore, the psyllium fiber utilized preferably has high purity, being about 85% to about 100% pure, and more preferably being about 95% to about 100% pure.

The calcium lactate coated psyllium composition comprises from about 85% to about 99.5%, preferably from about 85% to about 98.5%, and more preferably from about 90% to about 97%, psyllium fiber by weight of the coated compositions. (b) Calcium Lactate Coating: According to the present invention, calcium lactate is used to coat the psyllium fibers. The term coat, as used herein, - 7 means attaching the coating material (calcium lactate and/or Type A gelatin, if it is used) to the psyllium fiber, preferably by forming a layer of coating material on or around the psyllium fibers. One source of calcium lactate is a granular calcium lactate pentahydrate sold by Gallard-Schlesinger Industries Inc., NY.

The coating of the psyllium fiber may be achieved by spraying or otherwise wetting the psyllium fiber with an aqueous solution of calcium lactate, preferably an aqueous solution of calcium lactate containing 10% calcium lactate. (Preferred methods for coating the psyllium fiber are described in more detail hereinafter.) The calcium lactate coated psyllium compositions typically comprise from about 0.5% to about 10%, preferably from about 3% to about 7%, of calcium lactate by weight of the coated composition. (c) Tvoe A Gelatin Coating; A preferred optional component useful in the psyllium fiber coating is Type A gelatin. The term Type A gelatin, as used herein, means a gelatin formed by acid hydrolysis with an iso20 electric point of about 8. An example of a Type A gelatin which can be used herein is pigskin gelatin, Type A, 275 Bloom manufactured by Knox Gelatin Inc., Saddle Brook, New Jersey.

Preferably, the Type A gelatin 1s applied as a further coating to the calcium lactate coated psyllium fiber. This preferably may be achieved by spraying or otherwise wetting the calcium lactate coated psyllium fiber with an aqueous mixture of Type A gelatin, preferably 10% by weight of the aqueous composition. The calcium lactate coated composition may comprise from about 0% to about 5%, preferably from about 1.5% to about 2.5% of Type A gelatin by weight of the coated composition.

Baked Cookie Compositions Containing Psyllium: The present Invention further relates to high fiber psylliumcontaining baked cookie compositions comprising calcium lactate coated psyllium fiber. These baked cookie compositions comprise: (a) calcium lactate coated psyllium fiber; (b) Insoluble dietary fiber; (c) shortening component; (d) flour component; (e) sugar - 8 component; and (f) water. The essential and optional components for use in compositions of the present invention, and the amounts to be utilized, are described In detail hereinafter. (al Calcium Lactate Coated Psyllium: The present cookie compositions comprise psyllium fiber coated with calcium lactate (and preferably also Type A gelatin) as described hereinbefore. The baked cookie compositions of the present invention essentially comprise from about 10% to about 20% calcium lactate coated psyllium fiber, preferably from about 11% to about 18% calcium lactate coated psyllium fiber, and more preferably from about 12% to about 15% calcium lactate coated psyllium fiber, by weight of the baked composition. (bl Insoluble Dietary Fiber: The present cookies also preferably comprise insoluble dietary fiber. The term insoluble dietary fiber, as used herein, means the water insoluble, substantially non-swellable component of fiber material safe for human Ingestion which is non-d1gestible and non-metabolizable by humans.

A wide range of materials containing insoluble dietary fiber may be used In the present invention. Preferred are cereal brans and mixtures thereof, due to their relatively high content of insoluble dietary fiber. Also preferred is that these cereal brans comprise at least about 75% of the insoluble dietary fiber. Cereal brans useful in the present invention Include those selected from the group consisting of wheat, corn, barley, rye, oats and mixtures thereof. Most preferred are oat or corn. The components of the Insoluble dietary fiber from these cereal brans are known to be cellulose, hemlcellulose and lignin.

When the insoluble dietary fiber content of a composition of the present Invention 1s to be determined, an analytical technique which may be used is disclosed in the Association of Analytical Chemist publication Total Dietary Fiber: AOAC Collaborative Study, January 25, 1982, incorporated herein by reference in its entirety. This technique utilizes enzymatic and chemical proce35 dures to isolate the dietary fiber. When wheat bran or corn bran - 9 for example is treated according to this AOAC method, the recoverable dietary fiber 1s an insoluble fiber. The bran is first treated with a solvent, e.g., petroleum ether or hexane, to remove the fat. The defatted bran is then digested enzymatically with protease. Finally, the bran is treated with alpha or beta-amylase and amyloglucosidase. The recoverable material is protein-free, fat-free and carbohydrate-free insoluble dietary fiber. The insoluble dietary fiber content of a variety of dietary fiber sources are also disclosed in publications, including for example Plant Fiber in Foods by James W. Anderson, M.D. (published by the HCF Diabetes Research Foundation, Inc., Lexington, Ky.; 1986), incorporated by reference herein in its entirety.

The baked cookie compositions of the present invention comprise from about 0% to about 17%, preferably from about 3% to about 17% of an insoluble dietary fiber, more preferably from about 5% to about 10% insoluble dietary fiber, and most preferably from about 6% to about 8% insoluble dietary fiber, by weight of the baked compositions. (c) Shortening Component: The present cookie compositions further comprise a shortening component. Fats which can be used as the shortening component can be any of the usual fat stocks employed in preparing liquid, fluid, plastic, or solid shortenings, preferably having a solid content of less than about 25 at room temperature, more preferably having a solid content of less than about 10 at room temperature, and most preferably having a solid content of about 0 at room temperature. Various fats such as cottonseed oil, soybean oil, lard, and other vegetable, animal and marine fats, or mixtures thereof, either unhydrogenated or in various stages of hydroge30 nation, can be used. Suitable shortening components can also be formulated with non-absorbable, non-digestlble fatty acid esters of polyols, in particular sucrose polyesters (disclosed 1n U.S. Patent 4,005,196 to Jandacek et al., issued January 25, 1977, which is incorporated by reference herein 1n Its entirety,, and/or other non-nutritive or reduced calorie fat substitute materials suitable for use in the present compositions. - ίο · The baked cookie compositions of the present invention essentially comprise from about 10% to about 20% of the shortening component, preferably from about 13% to about 19% shortening component, and more preferably from about 15% to about 18% shorten ing component, by weight of the baked cookie composition. id) Flour Component: The present cookie compositions also comprise a flour component. Any type of flour which is suitable in cookie doughs can be used in the present invention. For example, suitable flours include wheat flour, rye flour, corn flour, cottonseed meal, and sorghum flour. Preferably, wheat flour is used in preparing the cookie compositions for the present invention. This flour can be bleached or unbleached. Furthermore, starches may constitute a portion of the flour component of the present compo15 sitions (preferably less than about 5% of the baked composition).

Most preferred are cookie compositions comprising pregelatinized food starch (e.g., pregelatlnized wheat starch; pregelatinized corn starch). Examples of such starches include: Sta-Mist 7415 starch, Sta-Mist 463 starch, and Sta-Mist 454 starch (all sold by A.E. Staley Manufacturing Company; Decatur, Illinois). The baked cookie compositions preferably comprise from about 1% to about 4%, and more preferably from about 1.5% to about 3%, of pregelatinized food starch by weight of the baked cookie composition.

The baked cookie compositions of the present invention comprise from about 10% to about 40% flour component, preferably from about 15% to about 35% flour component, and more preferably from about 17% to about 30% flour component, by weight of the baked cookie compositions.

(¢) Sugar Component: The present compositions also comprise a sugar component. Suitable sugar components include sucrose, invert sugar syrups, brown sugar, corn syrup solids, fructose, dextrose (glucose), honey, molasses, maple syrup and the like. Particularly preferred sugar components are sucrose, fructose and corn syrup solids. • π The baked cookie compositions of the present invention comprise from about 5% to about 40% of a sugar component, preferably from about 20% to about 40% of a sugar component, and more preferably from about 25% to about 35% of a sugar component, by weight of the baked compositions. if) Water: The cookie compositions of the present invention also comprise water in the range of from about 1.5% to about 3.5%, preferably from about 2% to about 3%, and more preferably about 2.0% to about 2.5%, by weight of the baked composition. Thus, while the dough prior to baking contains substantially more water than this, the dough is baked for a time and at a temperature sufficient to reduce the water content in the present cookie compositions to this level.

The water content of the cookie dough prior to baking is typically in the range of from about 5% to about 15% by weight of the dough. It is to be noted that the weight percentages of the essential components hereinbefore stated are by weight of the cookie composition following baking. The weight percentages of these essential components in the dough are therefore proportionally reduced by an amount which depends on the level of water present 1n the dough. Finally, it 1s preferred that the cookie dough be baked soon after preparation since storage of the dough could adversely effect the efficacy and/or aesthetics of the cookie. (g) Optional Components: The cookie compositions of the present Invention may further optionally comprise other components compatible with the psyllium and other essential cookie components, and which are suitable for ingestion. In particular, such components must not significantly reduce the efficacy of the psyllium for the therapeutic uses described herein (especially Taxation and/or cholesterol reduction).

One such preferred optional component is one or more emulsi35 fiers, frequently referred to as dough conditioners because they are used to control the consistency of the dough. Suitable - 12 optional emulsifiers include mono- and diglycerides and fatty acids, sucrose partial fatty acid esters, sorbitan esters of fatty acids, polyoxyethylene sorbitan esters of fatty acids, propylene glycol esters, polyethylene glycol esters, ethoxylated mono- and diglycerides, fumarated esters of monoglycerides or their alkali metal salts, alkanoyl lactylates or their metal salts, lecithins, and the like. Specific dough conditioners include sorbitan monostearate (Span 60), polyoxyethylene sorbitan monostearate (Tween 60), propylene glycol monostearate, glycerol lactopal10 mitate, sodium stearoyl fumarate, calcium stearoyl-2-1actylate, ethoxylated monoglycerides and lecithin. The amount of emulsifier can be varied to obtain the dough properties desired.

Another preferred optional component 1s one or more leavening agents. Non-yeast leavening agents include a source of carbon dioxide such as sodium bicarbonate or potassium bicarbonate, alone or in combination with a leavening acid such as monocalcium phosphate, dicalclum phosphate, sodium acid pyrophosphate, sodium aluminum sulfate, sodium aluminum phosphate, potassium acid tartrate and the like. The amount of leavening agent used depends on the particular agent employed and the leavening characteristics desired.

Other optional components which may be included 1n the dough are milk products such as whole milk, skim milk, buttermilk, whey, concentrated milk product (condensed or evaporated milk), dried milk products, nonfat milk powder, dry whole milk, modified whole milk and the like, egg products, including egg whites and egg yolks, protein sources (e.g., soy protein), non-nutritive artificial sweeteners (e.g., aspartame, acesulfame, saccharin, cyclamate), spices, cocoa powder, flavors such as vanilla, salt, color additives, preservatives, antioxidants and the like. Furthermore, other pharmaceutical active agents may be included as desired into the composition. Such actives include, for example, sennosldes (which are laxatives; preferably from about 0.04% to about 0.25% by weight of the baked cookie composition), analgesics, choles35 terol reduction agents, etc. - 13 · Method for Coating the Psyllium Fibers: Prior to preparing the cookie composition of the present invention, the psyllium fibers must be coated with calcium lactate to form the calcium lactate coated psyllium compositions as described hereinbefore. This coating aids in improving the aesthetics and mouthfeel of the present cookie compositions.

The first step in coating the psyllium fibers is preferably to prepare a calcium lactate solution comprising from about 1% to about 30% by weight of calcium lactate per weight of aqueous IQ solution, and preferably from about 10% to about 20% by weight of calcium lactate per weight of aqueous solution. The temperature of said solution preferably is adjusted to from about 20*C to about 80’C, and more preferably from about 40‘C to about 55*C.

Once the solution is prepared, the next step typically is to apply the calcium lactate solution onto the psyllium fibers. The application of calcium lactate solution is best achieved by spraying the calcium lactate solution onto the psyllium fibers with appropriate coating equipment known in the art. One example of such equipment is a GPCG 60-18 Inch Wurster coater. A detailed description of this type of equipment can be found In U.S. Patent 3,196,827, which is incorporated herein by reference in its entirety.

The psyllium fibers become coated by the calcium lactate in solution. This coating 1s accomplished by passing the psyllium fiber particles through a zone of finely atomized droplets of calcium lactate coating solution. As the coated psyllium fiber particles move up and away from the coating nozzle, the coating begins to solidify as the particles dry and the coated psyllium fiber is formed. Spraying is preferably continued until the coating of calcium lactate comprises from about 0.5% to about 10% by weight of the psyllium fiber, and more preferably from about 3% to about 7% by weight of the psyllium fiber. The calcium lactate coated psyllium fiber is then preferably dried to a moisture level of from about 5% to about 10%, and most preferred 1s a moisture x level from about 7% to about 8%. - 14 If desired, the optional Type A gelatin coating may be applied to the calcium lactate coated psyllium fibers. This may be achieved by first dissolving Type A gelatin 1n an aqueous solution comprising from about 2% to about 20%, and preferably from about 8% to about 15% of a Type A gelatin per weight of aqueous solution. The Type A gelatin solution is then adjusted to a temperature of from about 38*C to about 70’C, and preferably from about 40’C to about 55’C, so that the temperature is not too low to cause the Type A gelatin to reach a viscosity greater than 500-1000 cps, nor too high to cause extensive hydrolysis of the Type A gelatin. This Type A gelatin solution may then be applied in the same manner as the calcium lactate coating, described hereinabove, until the coating of Type A gelatin comprises from about 1% to about 5% by weight of the psyllium fiber, and more preferably from about 1.5% to about 2.5% of a Type A gelatin by weight of the psyllium fiber. Preferably, the Type A gelatin is sprayed onto core material consisting of the calcium lactate coated psyllium fibers.

Method for Making the Present Cookie Compositions: While the dough to be baked to form the present cookie compositions may be prepared in any manner which does not substantially reduce the efficacy of the psyllium for the therapeutic uses described herein (especially laxation and/or cholesterol reduction), the present Invention further relates to a method for preparing the present cookie compositions. This method comprises the steps of: (a) coating the psyllium fibers with calcium lactate and, optionally, Type A gelatin; (b) mixing to a uniform mass either sequentially or all at once the calcium lactate coated psyllium fiber (and preferably the insoluble dietary fiber) with the remaining components of the cookie dough; and (c) baking the dough to reduce the water content of the cookie composition to within from about 1.5% to about 3.5% by weight of the baked cookie composition. - 15 More preferred is the method comprising the steps of: (a) coating the psyllium fibers with calcium lactate and Type A gelatin; (b) mixing to a uniform mass the calcium lactate coated psyllium fiber and insoluble dietary fiber with a saturated aqueous solution of sugar components (wherein said saturated sugar solution comprises from about 12% to about 28% of water by weight of the saturated sugar solution) and a shortening component; (c) mixing the flour component with the mass following step (b); and (d) baking the dough to reduce the water content to within from about 1.5% to about 3.5% by weight of the baked cookie composition.

Temperature and time conditions generally suitable for baking cookie compositions can be used in preparing the baked cookie compositions of the present invention. Typically, the cookie dough is baked at a temperature of from about 325' to about 420*F (from about 162' to about 216'C), for from about 9 to about 5 minutes (depending on the baking temperature). Preferably, the cookie dough is baked at a temperature of from about 335* to about 410'F (from about 168' to about 210'C), for from about 8 to about 7 minutes. The particular baking conditions employed depend upon the size of the cookie dough being baked, the particular level of water desired 1n the final product, the particular oven used, and like factors. The term baking, as used herein, means radiant, conductive, or convective exposure to energy of a type which imparts thermal energy to the cookie dough being baked. It thus includes conventional, convection, dielectric and microwave oven baking.

Methods of Treatment: The present Invention also relates to a method for providing laxation and regulating bowel function for a human 1n need of such treatment. This method comprises administering to a human 1n need of such treatment a safe and effective amount of a psylliumcontaining cookie composition of the present Invention. Ingestion of from about 2.5 grains to about 30 grains per day of the psyllium fiber in a cookie composition according to the present Invention is appropriate in most circumstances to produce laxation. - 16 However, this can vary with the size and condition of the patient, and such matters will, of course, be apparent to the attending physician. However, since the psyllium material is nontoxic, even higher ingestion levels can be used without undue side effects. A typical dose for laxation purposes involves administering from about 3 to about 15 grams of psyllium fiber in one dose.

The present invention further relates to methods for reducing serum cholesterol levels in humans. These methods comprise orally administering to a human in need of having a lowered blood choles10 terol level a safe and effective amount of a psyllium-containing cookie composition of the present invention. Ingestion of compositions of the present invention comprising amounts sufficient to administer from about 2.5 grams to about 30 grams per day of psyllium fiber, preferably from about 5 grams to about 15 grams, is appropriate in most circumstances. However, this can vary with the size and condition of the patient, and the patient's blood cholesterol level. Such matters will, of course, be apparent to the attending physician. However, since the psyllium material is nontoxic, even higher ingestion levels can be used without undue side effects, keeping in mind the materials herein have the hereinbefore noted laxative effect.

Treatment of the patient to reduce serum cholesterol levels comprises chronic ingestion in order to lower and maintain the lowered cholesterol levels. Dally ingestion is preferred, and a dally ingestion of from about 5 grams to about 15 grams of the psyllium fiber 1s most commonly used, with said ingestion preferably being at 2 or 3 regularly spaced intervals throughout the day. Again, depending on the patient's size and cholesterol level 1n the patient's blood, this can be varied.

The following examples further describe and demonstrate embodiments within the scope of the present invention. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the present invention as many variations thereof are possible without departing from the spirit and scope. - 17 EXAMPLE I Cinnamon Spice Cookies A psyllium-containing cookie composition according to the present invention is prepared having the following components: Component Wet Weight % (by weight of dough) Fructose 6.91 Sucrose 17.62 Molasses 0.50 RO Water3) 3.51 Coated Psyllium b, 13.70 Oat Fiber c) 6.51 Corn· Oil d) 15.03 Soy Lecithin 1.00 RO Water 3.50 Sodium Bicarbonate 0.20 Flour e) 18.80 Rolled Oats 0 9.02 Vanilla Flavor 0.20 Butter Flavor 0.20 Cinnamon 0.90 Nutmeg 0.25 Starch 2.00 Ascorbic Acid 0.15 100.00 a) R0 water - reverse osmosis purified water b) Steam sanitized, sized psyllium muclllold coated with calcium lactate (5%) and Type A gelatin (1.8%) as described hereinafter c) 80% mlcrofine oat hull fiber sold by Canadian Harvest, St. Thomas, Ontario, Canada; approximately 80% insoluble fiber d) Distributed by Gateway Food Products, Dupo, Illinois e) Unbleached, undried cookie flour sold by H. Nagel & Co., Cincinnati, Ohio About 6.2% insoluble dietary fiber - 18 g) Sta-Mist 741S Starch supplied by A.E. Staley Manufacturing Company, Decatur, Illinois The manufacturing procedure 1s as follows: A. Procedure to coat the psyllium fiber: 1. Prepare a 10% solid aqueous calcium lactate solution (using calcium lactate pentahydrate sold by Gallard-Schlesinger Industries, Inc., Carle Place, New York), and adjust the solution temperature to approximately 50*C; 2. Adjust the GPCG 60-18 Wurster coater to the following parameters: (a) fluidizing air volume 350-400 cubic feet/minute (b) atomizing air pressure 4.0 bar (c) inlet air temperature 72*C-77*C (d) outlet air temperature 34‘C-40*C (e) nozzle size 1.2mm (f) pump Rate 300 grams/min. (g) partition height 22.5 in. (h) partition gap 0.75 in. (i) run time 70 min. 3. Spray the psyllium fibers using the Wurster coater, described hereinabove, until the psyllium fibers are encapsulated with 5% calcium lactate by weight of the psyllium fiber. 4. Dry the calcium lactate-encapsulated psyllium fibers to a moisture level of 7.7%.

. Prepare a 10% solids aqueous gelatin solution by dissolving pigskin gelatin Type A, 275 bloom (sold by Knox gelatin, Inc., Saddle Brook, New Jersey) and adjust the solution temperature to 50*C. 6. Adjust the GPCG 60-18 Wurster coater to the following parameters: (a) fluidizing air volume 600 cubic feet/minute (b) atomizing air pressure 4.0 bar (c, inlet air temperature 64*C-76*C (d) outlet air temperature 37*C-42*C (e) nozzle size 1.2 mm (f) pump rate 265 grams/min. - 19 (g) partition height 22.5 1n. (h) partition gap 0.75 1n. (1) run time 38 m1n. 7. Spray the calcium lactate-encapsulated psyllium fibers, using the Wurster coater, described hereinabove, until the calcium lactate coated psyllium fibers are coated with 1.8% Type A gelatin by weight of the calcium lactate coated psyllium fiber.

A suitable alternate coating may be prepared for the psyllium fiber by deleting steps (5} through (7) and coating the psyllium fiber with only calcium lactate, using the procedure described in steps (1) through (4} hereinabove.

B. Procedure for manufacturing psyllium-containing cookie composition: 1. Add fructose, 12.33% sucrose by weight of dough, molasses and RO water to the mixer and mix 2 minutes (Sweet Dough Mixer sold by Peerless Machinery Corporation, Sidney, Ohio; at 22 rpm); 2. Add calcium lactate coated psyllium, oat fiber, corn oil and lecithin to the mixer and mix 2 minutes; 3. Add starch, RO water, cinnamon, nutmeg, ascorbic acid, vanilla and butter flavor to the mixer and mix for 1 minute; 4. Add flour and soda to the mixer and mix 2 minutes; . Add remaining portion of the sucrose, 5.29% by weight of dough, and mix for 2 minutes; 6. Add oats and mix for 1 minute, scrape down and mix another minute and 45 seconds; 7. Empty finished dough batch Into trough; 8. Empty trough into rotary dough hopper and rotary mold rectangles having correct dimensions (approx. 6.35cm length X 4.1cm width X 0.76cm height); 9. Bake In a 3 zone oven (Wernalre Automatic Recirculating Oven; Werner Lahara, Grand Rapids, Michigan) for 7-8 minutes [(approximate zone temperature between 325-360*F (162 to 182*C); dictated by quality]; - 20 io. Allow to cool on a wire mesh belt for approx. 10 minutes. These baked cookies contain the following amounts of essential Ingredients: 13.05% psyllium fiber; 0.76% calcium lactate; 0.31% Type A gelatin; 7.08% Insoluble dietary fiber; 16.74% shortening component; 18.22% flour component; 27.32% sugar component; and 2.2% water.

Consumption of 2 of these cookies dally by a person in need of laxatlon provides effective laxative benefits and regulates bowel function. These cookies are convenient to use and provide psyllium 1n a very palatable form.

Substitution of about one-third of the corn oil component 1n this cookie composition with a non-absorbable, non-dlgestlble sucrose polyester (a mixture of sucrose hexa-, hepta-, and octaesters of soybean oil fatty acids) provides a reduced calorie cookie composition according to the present Invention. These cookies are also particularly well suited for use In reducing serum cholesterol levels 1n humans In need of such benefit. Ingestion of 6 of these cookies, taken In portions of 2 cookies at three regularly spaced Intervals throughout the day, 1s desirable for this purpose.

Claims (14)

1. Calcium lactate coated psyllium fiber composition comprising: (a) from 85% to 99.5% psyllium fiber; (b) from 0.5% to 10% of calcium lactate coating on the psyllium fiber; and (c) from 0% to 5% of Type A gelatin coating on the psyllium fiber.

2. Calcium lactate coated psyllium fiber composition according to Claim 1 wherein said composition is manufactured by a process wherein the psyllium fibers are first coated with calcium lactate followed by coating with Type A gelatin.

3. Psyllium-containing baked cookie composition comprising: (a) from 10% to 20% calcium lactate coated psyllium fiber; (b) from 0% to 17% of an insoluble dietary fiber; (c) from 13% to 20% of a shortening component; (d) from 10% to 40% of a flour component; (e) from 5% to 40% of a sugar component; and (f) from 1.5% to 3.5% water.

4. Psyllium-containing baked cookie composition according to Claim 3 wherein the calcium lactate coated psyllium fiber comprises, by weight of the coated psyllium fiber: (a) from 85% to 99.5% psyllium fiber; (b) from 0.5% to 10% of calcium lactate coating on the psyllium fiber; and (c) from 0% to 5% of a Type a gelatin coating on the psyllium fiber.

5. Psyllium-containing baked cookie composition according to Claim 3 or 4, wherein the calcium lactate coated psyllium fiber comprises from 3% to 7% calcium lactate by weight of the coated psyllum fiber.

6. Psyllium-containing baked cookie composition according to any of Claims 3-5, wherein the calcium lactate coated psyllium fiber comprises, by weight of the coated psyllium fiber: (a) from 3% to 7% of calcium lactate coating on the psyllium fiber; and (b) from 1.5% to 2.5% of a Type A gelatin coating on the calcium lactate coated psyllium fiber; and wherein the psyllium fibers are first coated with calcium lactate followed by coating with Type A gelatin.

7. Psyllium-containing baked cookie composition according to any of Claims 3-6 wherein the insoluble dietary fiber comprises from 3% to 17% of one or more cereal brans selected from the group consisting of wheat, corn, barley, rye, oats and mixtures thereof.

8. Psyllium-containing baked cookie composition according to any of Claims 3-7 wherein the shortening component comprises a non-absorbable, nondigestible fatty acid ester of polyols.

9. Psyllium-containing baked cookie composition according to any of Claims 3-8 further comprising sennoside.

10. A method for making a psyllium-containing baked cookie composition according to any of Claims 3-9, said method comprising the steps of: (a) coating the psyllium fibers with calcium lactate and, optionally, Type A gelatin; (b) mixing to a uniform mass, either sequentially or all at once, the calcium lactate coated psyllium fiber with the remaining components of the cookie dough; and (c) baking the dough to reduce the water content of the cookie composition.

11. A calcium lactate coated psyllium fiber composition according to Claim 1, substantially as hereinbefore described and exemplified.

12. A psyllium-containing baked cookie composition according to Claim 3, substantially as hereinbefore described and exemplified.

13. A method for making a psyllium-containing baked cookie composition according to Claim 3, substantially as hereinbefore described and exemplified.

14. A psyllium-containing baked cookie composition according to Claim 3, whenever made by a method claimed in Claim 10 or 13.